UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` ------------------------------------------------
`
`Page 1
`
` MYLAN LABORATORIES LIMITED,
`
` Petitioner,
`
`-vs-
`
` AVENTIS PHARMA, S.A.,
`
` Patent Owner.
`
` PATENT NO. 8,927,592
`
` ------------------------------------------------
`
`
`
` DEPOSITION OF RAHUL SETH, DO
`
` Syracuse, New York
`
` Friday, April 14, 2017
`
` 9:00 a.m.
`
`Reported by:
`
`PAMELA PALOMEQUE, NYRCR, RPR, CRR
`
`Job no: 18557
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` ------------------------------------------------
`
`Page 1
`
` MYLAN LABORATORIES LIMITED,
`
` Petitioner,
`
`-vs-
`
` AVENTIS PHARMA, S.A.,
`
` Patent Owner.
`
` PATENT NO. 8,927,592
`
` ------------------------------------------------
`
`
`
` DEPOSITION OF RAHUL SETH, DO
`
` Syracuse, New York
`
` Friday, April 14, 2017
`
` 9:00 a.m.
`
`Reported by:
`
`PAMELA PALOMEQUE, NYRCR, RPR, CRR
`
`Job no: 18557
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 2
`
` Deposition of RAHUL SETH, D.O., held
`
` at the offices of SHERATON SYRACUSE
`
` UNIVERSITY HOTEL & CONFERENCE CENTER,
`
` Syracuse, New York, on April 14, 2017,
`
` before PAMELA PALOMEQUE, NYRCR, RPR, CRR,
`
` and Notary Public in and for the State of
`
` New York.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`1 2 3 4 5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 3
`
` APPEARANCES:
`
` For the Petitioner:
`
` WILSON SONSINI GOODRICH & ROSATI
` Attorneys at Law
` 701 Fifth Avenue
` Suite 5100
` Seattle, WA 98104-7036
` BY: JAD MILLS, ESQ.
` 206.883.2500
` jmills@wsgr.com
`
` For the Patent Owner:
`
` FITZPATRICK, CELLA, HARPER & SCINTO
` Attorneys at Law
` 1290 Avenue of the Americas
` New York, New York 10104-3800
` BY: DANIEL J. MINION, ESQ.
` 212.218.2538
` dminion@fchs.com
`
`-and-
`
` BY: WHITNEY MEIER, ESQ.
` 212.218.2379
` wmeier@fchs.com
`
` *
`
`*
`
` *
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7 8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
` EXAMINATIONS
`
`Page 4
`
`1. Rahul Seth, DO
`
` EXAMINATION BY MR. MINION
`
` EXAMINATION BY MR. MILLS
`
` Page
`
` Line
`
` 5
` 142
`
` 4
` 6
`
` *
`
`*
`
` *
`
` EXHIBITS
`
` No.
`
` Description
`
` Page
`
` Line
`
` (No Exhibits Marked).....
`
` *
`
`*
`
` *
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`1
`
`2
`
`3
`
`4
`
`6
`
`7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` R A H U L S E T H, DO, having been called as a
`
` witness, being duly sworn by the notary public present,
`
`Page 5
`
` testified as follows:
`
` EXAMINATION BY MR. MINION:
`
`Q.
`
`I assume you have your Reply Declaration
`
` already. Do you need one?
`
`A.
`
`Q.
`
`I have one.
`
`I'm going to start off in paragraph 10 of your
`
` Reply Declaration.
`
` Go ahead. Have a read through that.
`
`A.
`
`Q.
`
`(Witness complies.)
`
`This sentence: Indeed, in many cases
`
` improvement of quality of life through symptom control,
`
` including pain alleviation via reduction in cancer cells,
`
` is a primary aim of mCRPC treatment.
`
` What did you mean by "in many cases"?
`
`A.
`
`Indeed, in many cases -- your question is
`
` phrased "in many cases." What I'm really referring to is
`
` that as an oncologist we are always trying to give
`
` patients overall survival, trying to control their
`
` disease as best we can and sometimes we cannot guarantee
`
` that. At the same time though, in many cases we are
`
` trying to control symptoms of pain through treatment.
`
` The analogy is small cell lung cancer is -- these
`
` patients, if they're metastatic small cell lung cancer,
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 6
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` they're always terminal 100 percent of the time; however,
`
` our teachings are that we treat patients despite having
`
` no ability to cure these patients, because we know that
`
` if we treat these patients, we will give them some
`
` quality of life in terms of reduction of pain and a
`
` better quality of life until the end.
`
` And in some of these cases of what we're
`
` saying for metastatic castrate prostate cancer
`
` resistance, we're not able to cure these patients;
`
` however, treating these patients will sometimes improve
`
` their quality of life by reducing hospitalizations,
`
` reducing the need for analgesics for pain medications
`
` and, therefore, giving them a better life until the end
`
` because we, as oncologists, cannot guarantee that every
`
` patient we see will get a benefit from treatment.
`
`Q.
`
`Understood. So when you say "improvement of
`
` quality of life through symptom control is a primary aim
`
` of mCRPC treatment," is that the primary aim of mCRPC
`
` treatment to improve quality of life?
`
`A.
`
`The improvement of quality of life is not the
`
` primary aim. It is part of -- it is part of a -- in all
`
` types of treatment we're not trying to make patients
`
` worse and give them a cure. We're also -- at the same
`
` time we're trying to give patients a better quality of
`
` life while we treat them. So it's not the. It is a goal
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 7
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` whenever we treat somebody with stage 4 cancers and lung
`
` cancer, small cell lung cancers, anything, you're always
`
` trying to give them some better quality of life because
`
` we cannot -- as you said, there are many aims we do for
`
` patients and I think quality of life is one of the
`
` desires we have for patients in the end, and I believe
`
` that is more about the palliative care nature of oncology
`
` that is now being practiced because anybody with stage 4
`
` lung cancer, anybody with stage 4 disease at all, we're
`
` involved in palliative care earlier for these patients to
`
` give them a better quality of life as we try to treat
`
` them.
`
`Q.
`
`When you treat a patient today with
`
` cabazitaxel, is your intention to provide a palliative
`
` benefit to that patient?
`
`A.
`
`Anybody with a metastatic castrate-resistant
`
` prostate cancer being treated with any of the agents that
`
` we have for metastatic prostate cancer treatments, part
`
` of the treatment is to help them have a better quality of
`
` life by treating the prostate cancer which in turn
`
` hopefully gives them a better overall survival if that
`
` is, you know, with the decreased time for progression or
`
` a progression-free survival, whatever statistics you want
`
` to follow, but that is the idea when we try to treat
`
` patients with metastatic castrate prostate cancer,
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 8
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` resistant patients. We are trying to help them.
`
`Q.
`
`What is it in terms of treating a patient with
`
` mCRPC with a taxane? How is it that the taxane can
`
` provide a palliative benefit?
`
`A.
`
`As I said prior to the second question before,
`
` one of the issues that we have when we treat patients
`
` with metastatic castrate prostate resistant cancer is to
`
` help them control their disease. If we control their
`
` disease, we're theoretically hoping for them to have less
`
` pain. If we're having them control their disease and
`
` having less pain, their quality of life will improve.
`
` Also, if we control their disease, we're also hoping that
`
` they have increased, progressively increased survival.
`
` We make them live longer by controlling their disease.
`
`Q.
`
`So I think what I'm trying to get at is, what
`
` is the relationship between what you say is controlling
`
` the disease and providing a palliative benefit to a
`
` patient with mCRPC?
`
`A.
`
`If you control the disease, you are then
`
` theoretically hopefully controlling the cancer's growth.
`
` You're also then controlling the patient's effect of pain
`
` from the growth of the cancer cells and, therefore, that
`
` is a palliative nature of controlling their life because
`
` they would have less pain; therefore, if they have less
`
` pain, they will be less dependent upon analgesic
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 9
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` medications. If they're dependent on less analgesic
`
` medication, they will have most likely more
`
` alert-oriented state instead of feeling pain, instead of
`
` being numbed from opioids, from analgesics that they use
`
` to control pain.
`
` And that is the nature of palliative care in
`
` the sense that you're controlling their palliative
`
` nature. Palliative meaning that we know metastatic
`
` prostate cancer is terminal. It is not curable. It
`
` is -- you're always trying to control it for long as you
`
` can, and when we control cancer diseases in the terminal
`
` state, we are then hoping and we are interpreting that as
`
` giving them palliative control of their disease.
`
`Q.
`
`So in terms of treating a patient with mCRPC,
`
` palliation, the principal -- the principal aspects of
`
` palliation is controlling pain?
`
`A.
`
`Repeat that last part you're saying about
`
` palliative?
`
`Q.
`
`So when -- I'm asking about palliation in
`
` mCRPC patients and you've talked twice about the idea is
`
` if you control their disease, the patient has less pain
`
` and they're less dependent on analgesic medications. Is
`
` that -- is there a relationship between palliation and
`
` pain control?
`
`A.
`
`Yes. So sorry, I didn't want to take that yes
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 10
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` back. What I'm trying to say is that palliation -- the
`
` definition of palliation can include controlling pain,
`
` yes, and decreasing their analgesic usage and I think the
`
` irony of this issue of palliation is that treatment is a
`
` form of palliation where intrinsically you think treating
`
` is not palliation; you're treating somebody. No.
`
` By treating somebody with cytotoxic agents or
`
` targeted medication for metastatic castrate prostate
`
` cancer resistant patients, we are palliating them because
`
` we're trying to control their disease that is causing
`
` them to be such -- to be in pain, to have a poor
`
` performance status, to have less appetite, to have more
`
` fatigue.
`
` The idea of treatment is to control the
`
` cancer, which also would then decrease their pain, give
`
` them more energy. That's the irony of what we do as
`
` oncologists because when you have somebody who has a
`
` terminal disease, most time you think don't do anything;
`
` they're terminal a disease. The irony is if you do give
`
` some sort of treatment to these patients, you may improve
`
` their quality of life, give them less pain, give them
`
` more energy, may give them more appetite, give them their
`
` life back. At the same time they're receiving treatment
`
` for a terminal disease. That is what palliation is
`
` really all about.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 11
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Q.
`
`I think I understand. So by virtue of giving
`
` a patient chemotherapy, you are providing a palliative
`
` benefit to that patient?
`
`A.
`
`By virtue of giving treatment in the form of
`
` chemotherapy of cytotoxic agents, of medications, yes,
`
` you are performing a palliative treatment for these
`
` patients.
`
`Q.
`
`Okay. And that's true regardless of whether
`
` that chemotherapy is actually controlling their disease
`
` or not?
`
`A.
`
`No, I think the word -- to answer your
`
` question appropriately, the last part of controlling, I
`
` don't think I would agree with at all because basically
`
` if you're giving a treatment and it's not controlling the
`
` cancer at all, the patient most likely will not have any
`
` palliative effects of giving a treatment. The choice of
`
` treatment usually typically has to hopefully control
`
` their disease.
`
` The eventuality of these patients is that they
`
` will die eventually. They are going to be terminal and
`
` the process of what we're doing as oncologists basically,
`
` is the road to the end basically if you will say, how
`
` smooth do you we make it or how disruptive do we make it.
`
` I can't control anything but if I know I can't control a
`
` cancer at the same time, the patient most likely will not
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 12
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` have a benefit in palliative care. Now, there are
`
` instances that you can give something to some patient,
`
` makes them feel better and then in the end you realize
`
` you didn't do anything. There's -- I can't look into
`
` that patient all the time and see it. Sometimes patients
`
` will have a placebo effect; I'm getting something and
`
` they feel better mentally and you realize it wasn't doing
`
` anything at all; therefore, there is debate about it. I
`
` think the word controlling, you can't use that word.
`
`Q.
`
`But even in that circumstance where if you
`
` look back and say I don't know if I've actually provided
`
` any benefit to the patient by treating them with that
`
` chemotherapy, you were still providing palliative care to
`
` that patient?
`
`A.
`
`To answer your question on that point of all,
`
` I do not know exactly what is happening with these
`
` patients when I give them treatment but I am trying --
`
` I'm attempting to provide palliative care for those
`
` patients by giving them treatments.
`
` And the classical teaching, to answer your
`
` question, is small lung cancer, when you look at as an
`
` oncologist -- when we look at it as POSAs, we're taught
`
` if a patient has a really bad performance status, 2 or 3,
`
` and they're bed bound, and they're small cell lung
`
` cancer, we're taught you get chemotherapy. Even though
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 13
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` they're gasping for air, small cell lung, sometimes the
`
` benefit of chemotherapy may be a few days or a few weeks
`
` but you know actively by giving them therapy treatment,
`
` you're giving them palliation and attempting that.
`
`Q.
`
`I think what I'm really trying to get at is if
`
` you have two separate patients on the same chemotherapy
`
` drug and you treat them over several cycles, and one of
`
` the patients you look at and you say they're telling me
`
` they have less pain; they've pulled back on their
`
` analgesics. The other patient, you're really not seeing
`
` any benefit in terms of pain; you're not seeing any
`
` benefit in terms of disease control. For both of those
`
` patients you are still providing a palliative benefit
`
` through therapy?
`
`A.
`
`For both of those patients you're attempting
`
` to give palliative therapy with your treatments. One
`
` patient, obviously you're presenting having decreased
`
` analgesics, a better quality of life and everything else
`
` like that. You're attempting to that. You do say, yes,
`
` that is palliative care therapy but the other patient
`
` clearly, whatever you're doing on him at this time is not
`
` theoretically having a response in a clinical setting in
`
` terms of decreased analgesics or anything. That other
`
` patient is not having a good palliative care response.
`
`Q.
`
`So can you determine in an individual patient
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 14
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` whether you're actually providing a palliative benefit?
`
` MR. MILLS: Objection, form.
`
`Repeat the question again?
`
`I'll ask it. Can a physician today determine
`
`A.
`
`Q.
`
` in an individual patient whether cabazitaxel is providing
`
` a palliative benefit to that patient?
`
` MR. MILLS: Objection, form.
`
`A.
`
`As a clinician today, whenever we're doing
`
` palliative care for patients with treatment, you have to
`
` use constitutional clinical judgments to see if you're
`
` helping these patients in a palliative setting regardless
`
` of using cytotoxic agents or targeted therapies.
`
` If a patient is on therapy and you see them
`
` suffering even more in terms of having more increased
`
` demand of analgesics, decreased performance status, the
`
` ECOG performance status which is their ability to live by
`
` themselves, ability to take care of themselves, ability
`
` to have decreased -- increasing fatigue, a loss of
`
` appetite, those things are clinical suspicions of
`
` worsening of the patient and, therefore, the palliative
`
` nature is not being successful and, therefore, you may
`
` want to use different therapies for that patient.
`
` So I don't think one person today can say
`
` exactly that every drug we use on every patient is being
`
` successful in palliating the patient.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 15
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Q.
`
`But by -- when you start a patient on
`
` cabazitaxel with the intention of providing a palliative
`
` benefit to that patient, by virtue of that intention you
`
` are actually providing palliative care to that patient?
`
` MR. MILLS: Objection, form.
`
`A.
`
`Anybody with a stage 4 carcinoma or a
`
` metastatic castrate prostate cancer resistant patient
`
` that we attempt to control their disease in essence is
`
` also being palliated. How successful we will be in that
`
` palliation is unknown to us and, therefore, we cannot
`
` guarantee each individual success but whenever we see a
`
` patient and we are attempting to treat them in a way, we
`
` are palliating -- in essence we're -- we're using
`
` palliative care at that time.
`
`Q.
`
`A.
`
`Right.
`
`And as a patient goes for treatment, we use
`
` clinical judgments.
`
`Q.
`
`When you determine that a patient has actually
`
` received palliative benefit from the administration of
`
` cabazitaxel, are you saying that they've received a
`
` palliative benefit over having not received any
`
` chemotherapy at all?
`
` MR. MILLS: Objection, form.
`
`Read your question again?
`
`So are you -- is a palliative benefit of a
`
`A.
`
`Q.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 16
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` drug in comparison to another drug? I mean, how do you
`
` determine whether a patient has had a palliative benefit
`
` from a drug?
`
`A.
`
`That's your question? How do -- so as a
`
` physician, as a medical oncologist, the clinical things
`
` we look at for palliative care nature is as stated before
`
` in the questions, is decreased demand of analgesics and
`
` increase in appetite and increase in their energy level,
`
` meaning a decrease in their fatigue. Overall,
`
` patients, when they come to you constitutionally, weight
`
` is stable or they're feeling fine; they're not feeling as
`
` sick; they're not feeling cancer-related pain. They're
`
` not having issues of -- you know, medically we can see
`
` that anemias, their hemoglobin, hematocrit do not
`
` decrease as much on therapies. Sometimes objectively for
`
` prostate cancer, we look at their PSAs. PSAs are
`
` decreasing. That means they seem to be having an
`
` objective response.
`
`Q.
`
`But is that in comparison to having not
`
` received any drug or in comparison to receiving some
`
` other drug?
`
` MR. MILLS: Objection, form.
`
`A.
`
`That statement -- as I said to you previously,
`
` if the other question was primarily your answer about how
`
` do you clinically see a patient getting a benefit from
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` treatments and that's not in comparison to say somebody
`
` who doesn't get a drug or somebody who got a different
`
` drug. That's just a patient when you see them
`
` individually one-on-one.
`
`Q.
`
`So if you go on 10, and back to paragraph 10,
`
` the last sentence: A person of ordinary skill would
`
` understand today and would have understood in 2008 that
`
` one of the purposes of administering a taxane such as
`
` docetaxel or cabazitaxel to a patient with mCRPC that has
`
` progressed during or after docetaxel is to prolong the
`
` survival of that patient.
`
` What do you mean by "prolong the survival of
`
` that patient"?
`
`A.
`
`So when we were previously talking about
`
` palliative care natures of treatments on metastatic
`
` castrate prostate cancer resistance, you're in turn also
`
` then hoping when patients get treated and responding in a
`
` palliative care nature that that may translate into a
`
` prolongation of the survival of the patient because
`
` you're controlling the disease, which in turn controls
`
` their symptoms and, therefore, giving them more of a
`
` palliative care control of their cancer.
`
` Because if you control the disease, you're
`
` theoretically hoping then that you're controlling --
`
` you're giving them more time to live by controlling their
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 18
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` cancer which in turn hopefully will control their
`
` symptoms.
`
`Q.
`
`But when you say prolong the survival of that
`
` patient, prolong the survival of that patient compared to
`
` what?
`
`A.
`
`So most times when we're using medications on
`
` patients for the purpose of controlling their cancer
`
` diseases, you're hoping that they're prolonging survival
`
` in general versus, you know, them unable to get the
`
` medications.
`
`Q.
`
`Okay. And the expectation today when
`
` administering cabazitaxel to a patient with mCRPC that
`
` has progressed during or after docetaxel is that you will
`
` prolong the survival of that patient as compared to how
`
` that patient would have done without having the benefit
`
` of cabazitaxel?
`
` MR. MILLS: Objection, form.
`
`A.
`
`I think in 2008 a person of ordinary skill
`
` today would have understood that one of the purposes of
`
` administering a taxane such as docetaxel or cabazitaxel
`
` to a patient with metastatic castrate prostate cancer has
`
` progressed during -- after docetaxel is to prolong the
`
` survival of the patient.
`
` I didn't say compared to anything else. Just
`
` you're hoping to give that patient a prolonged survival.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 19
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Q.
`
`But I think you said a moment ago as compared
`
` to them being unable to get the medication.
`
`A.
`
`I wasn't specifically saying cabazitaxel or
`
` anything. I'm just saying if you had a patient that was
`
` getting -- in terms of prolonging survival, if you're
`
` going to look statistically at prolonging survival when
`
` you see these patients, sometimes these patients, they're
`
` so sick they can't get anything at all; they can't eat or
`
` anything else. They've progressed. So when you see a
`
` patient and you want to give them something, in 2008, at
`
` that time, you could have used -- you could use
`
` cabazitaxel.
`
` Nowadays, in 2017 we have many options for
`
` patients so I don't think that is something you can
`
` compare so much from 2000 --
`
`Q.
`
`I'm just -- it's not clear to me -- I thought
`
` it was clear a minute ago. When you say a person of
`
` ordinary skill in the art would understand today and
`
` would have understood in 2008 that one of the purposes of
`
` administering a taxane to a patient with mCRPC that has
`
` progressed during or after docetaxel is to prolong the
`
` survival of that patient as compared to what would have
`
` happened if that patient were unable to get that
`
` medication?
`
`A.
`
`Unable to take any medication I would say.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 20
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Not that medication. Any medications.
`
`Q.
`
`Any medications, okay. So if today or in 2008
`
` a patient with mCRPC progresses during or after
`
` docetaxel, if they are administered cabazitaxel, that
`
` will prolong the survival of that patient compared to
`
` them taking nothing?
`
` MR. MILLS: Objection, form.
`
`A.
`
`The statement you just said to me is not
`
` absolutely true because there's no guarantee that if a
`
` patient does not get cabazitaxel after progression of
`
` docetaxel, that they absolutely would have a prolonged
`
` survival compared to somebody who did not get anything.
`
` Sometimes patients who didn't get anything, they may live
`
` longer but living as -- as they live longer without
`
` anything, they may have more symptoms of pain, of
`
` increased fatigue, but that person may live longer in
`
` spite of not getting anything.
`
`Q.
`
`So would a POSA understand that in 2008 that
`
` a -- the administration of cabazitaxel to a patient with
`
` mCRPC that has progressed during or after docetaxel --
`
` let me ask it a different way.
`
` Would a POSA -- sorry. If you administer
`
` cabazitaxel and prednisone, 20 to 25 milligrams per meter
`
` squared cabazitaxel to a patient with mCRPC that has
`
` progressed during or after docetaxel, are you inherently
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 21
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` prolonging the survival of that patient?
`
` MR. MILLS: Objection, form.
`
`A.
`
`The question you have answered is it is no
`
` inherently guaranteed that you're going to prolong a
`
` patient's life by giving them prednisone and cabazitaxel
`
` after somebody progresses on docetaxel. You could
`
` potentially give them prednisone alone and they may do
`
` inherently better with just prednisone after a
`
` progression of docetaxel. There's no guarantee of giving
`
` patient survival. You're attempting that. Your purpose
`
` is trying to give them prolonged survival, the patients,
`
` whenever you try to treat a patient and it doesn't have
`
` to be cabazitaxel after Taxotere. It could be prednisone
`
` after TAXOTERE. It could be dexamethasone.
`
`Q.
`
`So there's a difference in your mind between
`
` intending to prolong the survival of the patient by
`
` administering cabazitaxel versus actually prolonging
`
` survival of that patient?
`
`A.
`
`Whether I actually prolong the survival of a
`
` patient versus what I'm intending to?
`
`Q.
`
`A.
`
`Yes.
`
`I'm intending always to prolong their survival
`
` when I try to give somebody treatment but I cannot
`
` guarantee that when I treat a patient.
`
`Q.
`
`So there's a difference in your mind between
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 22
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` intending to prolong the survival of the patient by
`
` administering cabazitaxel versus actually prolonging
`
` survival of a patient by administering cabazitaxel?
`
` MR. MILLS: Objection, asked and
`
` answered.
`
`A.
`
`It's the same answer I gave you before. I'm
`
` always trying to prolong somebody's survival rate but I
`
` cannot guarantee that their survival will be prolonged.
`
`Q.
`
`Right. That is the same answer but that's
`
` not -- it's not the answer to my question. In your mind
`
` there is a difference between intending to prolong the
`
` survival of a patient by administering cabazitaxel versus
`
` actually prolonging survival of a patient by
`
` administering cabazitaxel?
`
` MR. MILLS: Same objection.
`
`A.
`
`Any time you try to treat a patient for
`
` metastatic castrate prostate cancer resistant patients,
`
` I'm intending to hopefully get a prolonged survival.
`
` Whether I get that or not, you do not absolutely know.
`
`Q.
`
`What is it specifically about cabazitaxel that
`
` gives you hope that it will prolong survival in a
`
` patient?
`
` MR. MILLS: Objection, form.
`
`A.
`
`To answer your question, I feel that it is a
`
` medication that has been listed and, hence, you can use
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 23
`
` it to get a response from patients who have metastatic
`
` castrate prostate cancer resistance and that response
`
` hopefully will give them a prolonged survival.
`
`Q.
`
`A.
`
`A response in terms of tumor response?
`
`So response can be, the definition can be in
`
` terms of decreasing PSA, hopefully decreasing the size of
`
` the tumors, hopefully giving them less pain as they get
`
` treatments.
`
`Q.
`
`What would a POSA have considered to have been
`
` the purpose of the TROPIC study in 2009?
`
` MR. MILLS: Objection, form.
`
`A.
`
`To better answer your question do you have the
`
` reference for the TROPIC study by any chance?
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`The protocol?
`
`Yeah.
`
`The actual protocol?
`
`TROPIC, yeah.
`
`I don't have the protocol with me, no.
`
` MR. MILLS: I'm not sure you're
`
` talking -- talking about the prior reference
`
` or the FDA papers.
`
` MR. MINION: I'm talking about the prior
`
` art.
`
`A.
`
`So what a POSA would take out of the TROPIC
`
` study?
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 24
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Q.
`
`No, no. Prior to -- prior to 2009, based on
`
` the prior art, what would a person of ordinary skill in
`
` the art have understood the purpose of TROPIC to be?
`
`A.
`
`I -- the best way to answer your question, I
`
` believe in the prior art prior to 2009, most of us would
`
` feel the TROPIC was to have cabazitaxel, to see how well
`
` cabazitaxel would succeed.
`
`Q.
`
`A.
`
`What do you mean?
`
`I don't have it in front of me. All right.
`
` In 2008, prior to 2009 I believe all of us thought the
`
` TROPIC study was the administration of cabazitaxel with
`
` prednisone and that was working for patients.
`
`Q.
`
`Well, that would have totally defeated the
`
` purpose of TROPIC; right?
`
` MR. MILLS: Objection, form.
`
`A.
`
`So whenever you have patients and you're
`
` trying to find something for them to use, you are --
`
` you're trying to read about -- you're trying to look for
`
` other things that a POSA, before 2009, say, okay, what is
`
` going to be successful, what are the potential new drugs
`
` that are coming out.
`
`Q.
`
`I'm not following you in terms of what is
`
` going to be successful.
`
`A.
`
`Q.
`
`Medications that you're using.
`
`But what does that have to go with the purpose
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`
`PUBLIC VERSION
`
`AVENTIS EXHIBIT 2258
`Mylan v. Aventis IPR2016-00712
`
`
`
`Page 25
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` of running TROPIC?
`
`A.
`
`Well, I would like to see TROPIC, Exhibit 1008
`
` or 1009. You guys don't have TROPIC for me here to look
`
` at so I can't refresh my memory completely.
`
`Q.
`
`A.
`
`Q.
`
`You want to see the TROPIC listing?
`
`Yes.
`
`Okay. Sure. We'll get them both. I've
`
` handed you Exhibits 1008 and 1009. I think you asked me
`
` earlier about the TROPIC protocol, neither 1008 or 1009
`
` is the TROPIC protocol; right?
`
`A.
`
`Q.
`
`Right. Well, 1008 has the arms.
`
`Right but doesn't have -- doesn't have the
`
` actual protocol of administration?
`
` MR. MILLS: Objection, form.
`
`A.
`
`Correct, Dan. Doesn't have the exact protocol
`
` of the administration of the drugs or anything like that.
`
` It just has the descriptive of the
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
